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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG FLAMENCO; SCREW
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ULRICH GMBH & CO. KG FLAMENCO; SCREW Back to Search Results
Model Number CS 8007-65-55
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Codes Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event 05/08/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer) exemption # e2014011 report is being submitted past 30 day deadline based on retrospective review conducted 6/21/2019.Original mdr (report 1 of 7) filed 6/2/2017.
 
Event or Problem Description
Screws and locking screws were getting threads damaged on final tightening.Report 7/7.
 
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Brand Name
FLAMENCO
Common Device Name
SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key8745547
Report Number9612420-2019-00021
Device Sequence Number11135101
Product Code MNI
UDI-Device Identifier04052536021116
UDI-Public4052536021116
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K102853
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/24/2019
Report Date (Section F) 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model NumberCS 8007-65-55
Device Catalogue NumberCS 8007-65-55
Device Lot NumberJ09204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/08/2017
Date Report to Manufacturer05/09/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/12/2017
Initial Report FDA Received Date06/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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